[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513871":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":52,"collaborators":54,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":20,"enrollmentInfo":76,"targetDuration":20,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Manchester University NHS Foundation Trust","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with liver cirrhosis eligible for HCC Surveillance","EXPERIMENTAL","Real-world HCC surveillance cohort will be exposed to Elecsys® GAAD in parallel with standard of care tests.",[13],"Diagnostic Test: Elecsys® GAAD",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Elecsys® GAAD","Elecsys® GAAD is a CE marked in vitro diagnostic (IVD) multivariate index assay, intended as an aid in the diagnosis of early-stage HCC. It provides a semi quantitative result by combining in an algorithm the quantitative measurements of Elecsys® AFP (alpha-fetoprotein) and Elecsys® PIVKA-II (protein induced by vitamin K absence II) levels in serum and plasma, with gender and age. Clinical evidence showed that Elecsys® GAAD had high performance in detecting HCC (sensitivity 86.5%), particularly early stage (sensitivity 78.9%), with 91.4% specificity for both early and all stages, out-performing current standard of care (Chan et al. 2021). Elecsys® GAAD may be integrated into current surveillance practice to increase early-stage HCC detection rate, reduce unnecessary onward investigations and patient anxiety.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Varinder Athwal, MRCP PhD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Varinder Athwal, PhD","CONTACT","0300 3309444","varinder.athwal@mft.nhs.uk",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Christopher Mysko, MClinEd MRCP","christopher.mysko@mft.nhs.uk",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Manchester","Greater Manchester","M13 9WL","United Kingdom","UK",{"type":43,"coordinates":44},"Point",[45,46],-2.23743,53.48095,{"lat":46,"lon":45},[49,51],{"name":32,"role":28,"phone":50,"phoneExt":20,"email":33},"07848471145",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[55,58,61,64],{"name":56,"class":57},"University of Manchester","OTHER",{"name":59,"class":60},"Roche Pharma AG","INDUSTRY",{"name":62,"class":63},"Unity Insights","UNKNOWN",{"name":65,"class":57},"Imperial College London","100513871","real-world-elecsys-gaad-implementation-and-validation-to-improve-surveillance-and-early-detection-of-hcc-100513871",false,"NCT05971108","Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC","Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma","REVISE-HCC","Inclusion Criteria:\n\n• Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance\n\nExclusion Criteria:\n\n* Pregnancy\u002Fbreast-feeding.\n* Patients who do not have liver cirrhosis\n* Patients who already have hepatocellular carcinoma\n* Any patient who is unable to understand, retain and weigh information to make an informed decision, will be excluded from the study. The investigators will use every opportunity, including tele-interpretation services to minimise this from happening.","ALL","18 Years",{"count":77,"type":78},600,"ESTIMATED","INTERVENTIONAL",[81],"NA","Patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (HCC) which implies significant mortality. At present current surveillance methods detect hepatocellular carcinomas at a late stage resulting in few treatment options for patients and, in the majority of cases, premature death.\n\nThe goal of this study is to implement Elecsys® GAAD in real-world hepatocellular carcinoma surveillance for those with liver cirrhosis.\n\nThe main questions it aims to answer are:\n\n* Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway increase early detection of HCC?\n* Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway reduce false positive tests and unnecessary confirmatory investigations?\n* Does the new surveillance pathway improve adherence?\n\nResearchers will compare Elecsys® GAAD with standard of care tests to see if it results in earlier detection of hepatocellular carcinoma and will explore potential improvements to the surveillance pathway.",[84,85],"Liver Cirrhosis","Hepatocellular Carcinoma",[87,88,89,90,91],"GAAD","hepatocellular carcinoma","cirrhosis","health inequalities","surveillance","2025-09-23",{"date":94,"type":95},"2025-09-24","ACTUAL",{"date":97,"type":95},"2024-01-08",{"date":99,"type":78},"2030-07-31",{"name":5,"class":6},1]